Trial Outcomes & Findings for Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® BGMS in Neonates Using Capillary Blood Samples (NCT NCT05467345)

Results Overview

At least 95% of all blood glucose results shall fall within ±12.5% of reference values (laboratory method) for glucose concentration ≥100 mg/dL(5.55 mmol/L )and within ±12 mg/dL(±0.67 mmol/L) at glucose concentrations \<100 mg/dL(5.55 mmol/L).

Recruitment status

COMPLETED

Target enrollment

120 participants

Primary outcome timeframe

1 day

Results posted on

2025-02-24

Participant Flow

Unit of analysis: blood samples

Participant milestones

Participant milestones
Measure	Testing of Neonatal Blood With BGMS The neonatal blood will be tested on two different BGMS: 1) Contour Next BGMS and 2) Contour Plus Elite BGMS. Each blood sample will be tested in duplicate on each BGMS. The results will be compared to the laboratory reference result.
Overall Study STARTED	120 240
Overall Study COMPLETED	120 240
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® BGMS in Neonates Using Capillary Blood Samples

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Testing of Neonatal Blood With BGMS n=240 blood samples The neonatal blood will be tested on two different BGMS: 1) Contour Next BGMS and 2) Contour Plus Elite BGMS. The results will be compared to the laboratory reference result.
Age, Categorical <=18 years	120 Participants n=120 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=120 Participants
Age, Categorical >=65 years	0 Participants n=120 Participants
Sex: Female, Male Female	53 Participants n=120 Participants
Sex: Female, Male Male	67 Participants n=120 Participants
Region of Enrollment United States	120 Participants n=120 Participants

PRIMARY outcome

Timeframe: 1 day

Population: Neonates in a hospital neonatal unit.

At least 95% of all blood glucose results shall fall within ±12.5% of reference values (laboratory method) for glucose concentration ≥100 mg/dL(5.55 mmol/L )and within ±12 mg/dL(±0.67 mmol/L) at glucose concentrations \<100 mg/dL(5.55 mmol/L).

Outcome measures

Outcome measures
Measure	Testing of Neonatal Blood With BGMS n=240 blood samples The neonatal blood will be tested on two different BGMS: 1) Contour Next BGMS and 2) Contour Plus Elite BGMS. The results will be compared to the laboratory reference result.
Number of Results From the Contour Next BGMSs Reference Values Within ±12.5% of Reference Values	240 blood samples

PRIMARY outcome

Timeframe: 1 day

Population: Neonates in a neonatal hospital ward.

At least 95% of values should be within ±12.5% of reference values (laboratory method) for glucose concentration ≥75 mg/dL(4.16 mmol/L) and within ±15 mg/dL(±0.83 mmol/L) at glucose concentrations \< 75 mg/dL(4.16 mmol/L).

Outcome measures

Outcome measures
Measure	Testing of Neonatal Blood With BGMS n=240 blood samples The neonatal blood will be tested on two different BGMS: 1) Contour Next BGMS and 2) Contour Plus Elite BGMS. The results will be compared to the laboratory reference result.
Number of Results From the Contour Plus Elite BGMSs Reference Values Within ±12.5% of Reference Values	240 blood samples

Adverse Events

Testing of Neonatal Blood With BGMS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jane Wallace

Ascensia Diabetes Care

Phone: 5748501467

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place